Biomet Interlok 75 MM fixed I-Beam Tibial Plate with… recallZ-2104-2011 · Biomet, Inc. · initiated Mar 3, 2011
Terminated All recalls posted in April 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
FDA root cause category: Packaging process control
What the company is doing
Biomet Orthopedics Inc initiated an electronic communication with Direct Accounts on March 3, 2011 and instructed them to quarantine and return all remaining/unused devices to the firm. For questions regarding this recall call 574-372-3983.
Recall details
- Recall number
- Z-2104-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 3, 2011
- Posted by the FDA
- Apr 28, 2011
- Recalling firm
- Biomet, Inc.
- Quantity
- 8
- Product code
- JWH
- FDA submissions
- K915132
- Distribution
- Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands
Product description
Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.
Code information (models, lots, serial numbers)
REF 141224, LOT J100921070
Other devices under the same FDA submission
48 devices cleared under K915132 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BIOMET KNEE SYSTEM 141215Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall3 reports
- Biomet® Knee System 141205Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- BIOMET KNEE SYSTEM 141314Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- Biomet® Knee System 141233Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- BIOMET KNEE SYSTEM 141233Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- BIOMET KNEE SYSTEM 141234Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Biomet® Knee System 141234Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- BIOMET KNEE SYSTEM 141224Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- BIOMET KNEE SYSTEM 141231Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Biomet® Knee System 141222Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Biomet® Knee System 141232Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer3 reports
- Biomet® Knee System 141235Biomet Orthopedics, LLC · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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